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Ethinyl Estradiol + Levonorgestrel

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Apr 28, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07502417A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female ParticipantsPHASE1 RECRUITING 16Mar 27, 2026Jul 1, 2026Apr 28, 20261 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel
Up to Day 5 in Period 1 and between Days 14-21 in Period 2

Cmax of Ethinyl Estradiol and Levonorgestrel.

Time to Cmax (Tmax) of Ethinyl Estradiol and Levonorgestrel
Up to Day 5 in Period 1 and between Days 14-21 in Period 2

Tmax of Ethinyl Estradiol and Levonorgestrel.

Terminal Phase Elimination Rate Constant (β) of Ethinyl Estradiol and Levonorgestrel
Up to Day 5 in Period 1 and between Days 14-21 in Period 2

β of Ethinyl Estradiol and Levonorgestrel.

Terminal Phase Elimination Half-Life (t1/2) of Ethinyl Estradiol and Levonorgestrel
Up to Day 5 in Period 1 and between Days 14-21 in Period 2

t1/2 of Ethinyl Estradiol and Levonorgestrel.

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Ethinyl Estradiol and Levonorgestrel
Up to Day 5 in Period 1 and between Days 14-21 in Period 2

AUCt of Ethinyl Estradiol and Levonorgestrel.

Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of Ethinyl Estradiol and Levonorgestrel
Up to Day 5 in Period 1 and between Days 14-21 in Period 2

AUCinf of Ethinyl Estradiol and Levonorgestrel.

Number of Participants with Adverse Events (AEs)
Up to Approximately 82 Days

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Period 1 & 2EXPERIMENTALIn Period 1, participants will receive a single dose of ethinyl estradiol and levonorgestrel. In Period 2, participants will receive multiple daily doses of ABBV-722 and a single dose of ethinyl estradiol and levonorgestrel.
Interventions
NameTypeDescription
Ethinyl Estradiol + LevonorgestrelDRUGOral
ABBV-722DRUGOral
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Laboratory values meet the criteria specified in the protocol. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). Exclusion Criteria: * History of an...

Countries:United States
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